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Estado : Publicado

Formato Idioma
PDF + ePub
Papel
  • CHF151
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Resumen

This document provides region-specific information for:

—    local submissions and approvals for vascular device-drug combination products (VDDCPs) in countries and regions around the world;

—    changes related to the drug-containing part and how they are evaluated by different local regions.

For implanted products, this document is considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.

This document is considered also as a supplement to ISO 12417-1, and any relevant device-specific standards, such as the ISO 25539 series specifying requirements for endovascular devices. This document also addresses VDDCPs that are not necessarily permanent implants.

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Informaciones generales

  • Estado
     : Publicado
    Fecha de publicación
     : 2022-07
    Etapa
    : Norma Internacional publicada [60.60]
  • Edición
     : 2
    Número de páginas
     : 29
  • Comité Técnico :
    ISO/TC 150/SC 2
    ICS :
    11.040.40 
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